Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU
FDA Recall Z-0358-2012 · Posted 2011-12-02
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeFCW
Date Initiated2011-10-14
Date Terminated2012-03-08
Product Quantity19
Reason for Recall
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
Firm Action
Integra sent an URGENT: Field Corrective Action letter dated October 14, 2011 to all affected customers via FedEx. The letter identified the affected product, the problem, and the actions to be taken with instructions to immediately inspect their inventory for potentially loose screws within the affected unit(s). If the unit(s) were observed with loose screws, the unit(s) were to be returned to Integra Surgical for repair and servicing. Customers were instructed to complete the Acknowledgement and Return Form per the instructions on the form. For questions call Integra Surgical Customer Service at 1-800-431-1123.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states of: Arizona, California, Colorado, Florida, Indiana, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Montana, Washington, Wyoming, and Puerto Rico, and the countries of: Australia, Germany, Italy, Japan, Netherlands, New Zealand, Pakistan, Sweden, Switzerland, and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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